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Metabolic Side-effects for Second-generation Antipsychotics

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ClinicalTrials.gov Identifier: NCT01280396
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Queen Mary Hospital, Hong Kong
Information provided by (Responsible Party):
Dr. Albert Kar-Kin Chung, The University of Hong Kong

Brief Summary:

Second-generation antipsychotics (SGAs), including clozapine, are commonly used nowadays as treatment for psychosis. There are increasing concerns about their related metabolic side-effects over weight gain, risks to cause glucose intolerance and hyperlipidemia, and a specific condition known as metabolic syndrome. All these side-effects might be associated with the increased risk of cardiovascular diseases and diabetes mellitus.

This study is to analyze the simple physical measurements (weight and height) and venous blood tests (for fasting blood glucose and lipid) results collected routinely since 2008 (recommended by the local hospital authority as a territory-wide "SGAs Monitoring Program") from those outpatients receiving SGAs (amisulpride, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone and ziprasidone) and/or clozapine, at a local psychiatric outpatient clinic in Hong Kong. The investigators hypothesized that there should be differential risks on metabolic side-effects amongst these SGAs.


Condition or disease
Mental Disorders

Study Type : Observational
Actual Enrollment : 241 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Metabolic Side-effects in Patients Receiving Clozapine and Second-generation Antipsychotics in an Outpatient Clinic
Study Start Date : November 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Clozapine

Group/Cohort
SGAs
patients receiving SGAs



Primary Outcome Measures :
  1. development of metabolic syndrome according to IDF criteria [ Time Frame: 1 year ]
    post treatment with second generation antipsychotics


Secondary Outcome Measures :
  1. change in BMI [ Time Frame: 1 year ]
    post treatment with second generation antipsychotics



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Out-patients in a public psychiatric out-patient centre
Criteria

Inclusion Criteria:

  • was ≥18 years of age
  • out-patients
  • had received any one of these antipsychotics: aripiprazole, amisulpride, clozapine, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone
  • consented to provide physical measurements and venous blood samples

Exclusion Criteria:

  • not consented to provide venous blood samples and/or physical measurement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280396


Locations
Hong Kong
Western Psychiatric Centre
Hong Kong, Hong Kong, 00000
Sponsors and Collaborators
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Investigators
Principal Investigator: Albert Kar Kin Chung, MBBS Department of Psychiatry, Queen Mary Hospital

Responsible Party: Dr. Albert Kar-Kin Chung, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01280396     History of Changes
Other Study ID Numbers: HKCTR-1205
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018

Keywords provided by Dr. Albert Kar-Kin Chung, The University of Hong Kong:
metabolic
SGAs
clozapine

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antipsychotic Agents
Clozapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Antagonists
GABA Agents